Enteral Extension Sets— 510(k) K203633

Name: FDA 510(k) clearance K203633
Creator: U.S. Food and Drug Administration
Published: 2021-08-19

Substantially Equivalent

GBUK Group, Ltd.

FDA 510(k) clearance K203633 for Enteral Extension Sets, Substantially Equivalent on 2021-08-19. Applicant: GBUK Group, Ltd.. Device class: 2.

Clearance details

Applicant: GBUK Group, Ltd.
Product code: Code PIF
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2020-12-11
Decision date: 2021-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Selby, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code PIF

product code PIF

Death: 13
Injury: 122
Other: 1
Total: 136

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.